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I.V. Enoxaparin or Unfractionated Heparin in Primary PCI: Acute and Long-term results G. M ONTALESCOT, DISCLOSURE : Research Grants to the Institution or Consulting/Lecture Fees from Abbott Vascular, Astra-Zeneca, Bayer, Biotronik, Boehringer-Ingelheim, Boston Scientific, Cleveland Clinic Foundation, Cardiovascular Research Foundation, Cordis, Daiichi-Sankyo, Duke institute, Eli-Lilly, Europa, Fédération Française de Cardiologie, Fondation de France, GSK, ICM, INSERM, Lead-up, Medtronic, Menarini, Nanospheres, Novartis, Pfizer, Sanofi-Aventis Group, Servier, Société Française de Cardiologie, The Medicines Company, TIMI group. ATOLL: Acute STEMI Treated with primary PCI and intravenous enoxaparin Or UFH to Lower ischemic and bleeding events at short- and Long-term follow-up (Investigator-driven study) G. Montalescot, M. Cohen, P. Goldstein, K. Huber, C. Pollack, U. Zeymer, E. Vicaut for the ATOLL investigators for the ATOLL investigators
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Intravenous enoxaparin vs. UFH in PCI 57% Major Bleeding (p=0.004) 23% Death or re-MI (p<0.001) Montalescot G et al. N Engl J Med 2006;355:1006 –17 Gibson MC et al. J Am Coll Cardiol 2007;49:2238–46 ?
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ATOLL Trial design STEMI Primary PCI 30-day and 6-month results Randomization as early as possible (MICU +++) Real life population (shock, cardiac arrest included) No anticoagulation and no lytic before Rx Similar antiplatelet therapy in both groups ENOXAPARIN IV 0.5 mg/kg with or without GPIIbIIIa UFH IV 50-70 IU with GP IIbIIIa 70-100IU without GP IIbIIIa (Dose ACT-adjusted) IVRS Primary PCI ENOXAPARIN SC UFH IV or SC
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Trial organization ACTION Study Group (Academic Research Organization, Paris): 1-Coordinating Center: 1-Coordinating Center: Institute of Cardiology, Pitié-Salpêtrière Hospital, Paris 2-Sponsor: 2-Sponsor: AP-HP (Assistance Publique-Hôpitaux de Paris) 3-Data center, Statistics: Unité Recherche Clinique, Lariboisière Hospital, Paris 4-International CRO: Pierrel-Hyperphar 4-International CRO: Pierrel-Hyperphar 5-Funding: AP-HP and unrestricted research grant from Sanofi-Aventis Group 5-Funding: AP-HP and unrestricted research grant from Sanofi-Aventis Group Steering Committee: G. Montalescot (Chair, France), M. Cohen (USA), P. Goldstein (France), K. Huber (Austria), C. Pollack (USA), E. Vicaut (France), U. Zeymer (Germany) Data Safety Monitoring Board: A. Cohen (Chair, France), M. Cucherat (France), A. Gitt (Germany) Core Laboratory: R. Dumaine, A. Samadi Clinical Event Committee: F. Philippe, P. Sabouret, F. Boccara, A. Bellemain, O. Gournay
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Main objectives 1° EP: –All-cause mortality at D30, –Complications of MI at D30 [resuscitated cardiac arrest, recurrent MI/ACS, urgent revascularization, stroke, peripheral or pulmonary embolism], –Procedure failure [definite stent thrombosis; B.O. use of GpIIB/IIIa; Non-TIMI 3 flow after PCI; ST resolution < 50% after PCI], –Non-CABG major bleeding during hospitalization Main 2° EP: All-cause mortality, Recurrent ACS or Urgent revascularization at D30 Main safety EP: Non-CABG major bleeding (STEEPLE definition) during hospitalization
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FINAL 30-DAY RESULTS
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Selected Baseline Characteristics UFH (n=460) ENOXAPARIN (n=450) Age, median (Q1;Q3) Age > 75 60 (52; 70) 17% (80) 59 (52; 71) 19% (85) Pre-hospital randomization71% (325)71% (318) Shock and/or cardiac arrest before sheath, % (n)5% (24)4% (17) Time from symptom onset to randomization—hr, median (Q1;Q3) 2h19 (1h26; 4h37) 2h33 (1h29; 4h50) Radial artery access, % (n) Other artery access, % (n) 66% (305) 34% (155) 69% (309) 31% (141) Glycoprotein IIb/IIIa inhibitors,% (n) 83% (382)77% (347) Clopidogrel < 300mg > 300 and < 600mg > 600 and < 900mg > 900mg 37% (171) 37% (172) 25% (113) 1% (4) 37% (168) 39% (174) 22% (101) 2% (7)
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Primary Endpoint Death, Complication of MI, Procedure Failure or Major Bleeding
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Main Secondary Endpoint (ischemic) Death, Recurrent ACS or Urgent Revascularization
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Consistent therapy Pre-specified analysis: no protocol violation (88%)
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Death or Complication of MI Death, resuscitated cardiac arrest, recurrent ACS, Urg Revasc, stroke, peripheral or pulmonary embolism
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Death or resuscitated cardiac arrest Death (any)
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Safety Endpoints Protocole definitions (STEEPLE) NS
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Death, Complication of MI or Major bleeding Net clinical benefit
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6-month Follow-up
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6-month results Follow-up on mortality 100% follow-up We used a Cox regression model to identify independent predictors of death at 6 months. We firstly performed univariate analysis and significant variables were introduced into a stepwise cox regression model
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Death over 6 months 0123456 0.00 0.02 0.04 0.06 0.08 0.10 Months Death ENOX UFH Log Rank Test: p=0.11 6.3% 7.0% 7.2% 3.8% 4.5% 4.7% =2.5%
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Independent correlates of death at 6 months Beta blockers, yes vs. no0.16 [0.08;0.32]<.0001 KILLIP II,III,IV vs. I3.87 [2.02;7.4]<.0001 Age >75 vs. <754.01 [2.2;7.29]<.0001 ACE yes vs. no0.32 [0.16;0.66]0.0021 MI location, anterior vs. other2.24 [1.27;3.94]0.0052 Prior heart failure, yes vs. no4.57 [1.37;15.31]0.0137 Prior COPD, yes vs. no3.15 [1.05;9.39]0.0401 Systolic BP [mmHg] (10 units increase)0.87 [0.77;0.97]0.0149 Prior stroke, yes vs. no3.10 [1.14;8.48]0.0273
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Conclusions In this 1 st head-to-head comparison between two anticoagulants in primary PCI, i.v. enoxaparin: Reduced serious ischemic events, on top of intense antiplatelet therapy Had a good safety profile, with a superior net clinical benefit Tended to reduce mortality over 6 months
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Special Thank to: INVESTIGATORS – Austria: WR. Benzer, K. Huber, F. Leisch, F. Weidinger – France: F. Adnet, M. Angioi, B. Barberon, JF. Benezet, JL. Bonnet, J. Boschat, B. Boulanger, D. Carrie, T. Chouihed, P. Coste, Y. Cottin, H. Courcoux, C. Cuvier, N. Danchin, JL. Ducasse, F. Duclos, P. Ecollan, S. Elhadad, E. Filippi, M. Freysz, F. Funck, S. Gallula, B. Gelée, A. Greffet, P. Henry, A. Jacquemin, T. Joseph, JM. Lablanche, H. Lardoux, H. Le Breton, B. Lederman, A. Margenet, G. Mehu, O. Nallet, F. Paganelli, M. Pansieri, L. Payot, C. Pouges, E. Salengro, C. Spaulding, G. Steg, O. Stibbe, E. Teiger, M. Thicoipe, C. Thuaire, J. Treuil, O. Wittenberg, O. Wolf – Germany: D. Andresen, C. Axthelm, Fischer, E. Girth, E. Hauptmann, U. Zeymer – USA: M.Cohen, F. Shamoon COMMITTEES – A Appaix-Bellemain, F Boccara, A Cohen, M. Cohen, M Cucherat, R Dumaine, A Gitt, P Goldstein, O Gournay, K Huber, F Philippe, C Pollack, P Sabouret, A Samadi, E Vicaut, U Zeymer PIERREL Research– L. Basso, L. Merlini, M. Mazzoleni ACTION study Group – ME. Assossou, M. Aout, B. Bertin, D. Brugier, JP. Collet, M. Courreges-Viaud, V. Gallois, P. Gallula, V. Jouis, S. Kabla, C. Misse, G. Ngouala, A. Pena, S. Paulsrud, N. Vignolles
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